A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (Omacetaxine Mepesuccinate) in the Treatment of Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation.

Trial Profile

A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (Omacetaxine Mepesuccinate) in the Treatment of Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation.

Completed
Phase of Trial: Phase II

Latest Information Update: 24 Aug 2016

At a glance

  • Drugs Omacetaxine mepesuccinate (Primary)
  • Indications Chronic myeloid leukaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors ChemGenex Pharmaceuticals; Teva Branded Pharmaceutical Products R&D; Teva Pharmaceutical Industries
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 02 Jun 2014 Duration of maintenance therapy changed from up to 2 years to 3 years.
    • 13 Feb 2014 The US FDA has approved omacetaxine mepesuccinate for injection based on results from this and another pivotal phase II trial according to a Teva Pharmaceuticals Industries media release.
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